MAUDE Adverse Event Report: MERIT MEDICAL 5 FRENCH VESSEL SIZING OMNI CATHETER

Lot Number E890745

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2016

Event Type  Injury  

Event Description

The catheter in question used during an operating room procedure either became stuck due to the patient's anatomy and needed to be dismantled to remove it, or it broke during the procedure.The surgeon had a difficult time removing the device.It has been saved and can be returned to the manufacturer if they can contact me.

• Brand Name: 5 FRENCH VESSEL SIZING OMNI CATHETER
• Type of Device: 5 FRENCH VESSEL SIZING OMNI CATHETER
• Manufacturer (Section D): MERIT MEDICAL
• MDR Report Key: 6140855
• MDR Text Key: 61430362
• Report Number: MW5066468
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: E890745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 64